CP-868,596 And CP-868,596 Plus AG-013736 In Combination With Docetaxel In Advanced Solid Tumors

Phase I Study To Determine The Maximally Tolerated Dose Of Oral, Daily CP-868,596 And CP-868,596 Plus AG-013736 When Given In Combination With Docetaxel Administered Every 3 Weeks To Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00949624

Enrollment

Registered

2009-07-30

Start date

2005-12-31

Completion date

2008-06-30

Last updated

2012-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

Keywords

PDGFr Inhibition;, VEGFr inhibition;, targeted therapy

Brief summary

A5301005 is a phase 1 study in patients with solid tumors which is testing the safety and tolerability of adding targeted agents to a standard chemotherapy. CP-868,596 is a platelet-derived growth factor receptor inhibitor (PDGFR) and AG-13736 is a vascular endothelial growth factor receptor inhibitor (VEGFR). This study will test the use of docetaxel (the standard chemotherapy) with either CP-868,596 or the combination of CP-868,596 and AG-13736.

Interventions

DRUGCP-868,596

Oral tablet 60 mg BID continuous

DRUGDocetaxel

Intravenous 75 mg/m2 every three weeks

DRUGAG-013736

Oral tablet 5 mg BID continuous

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Be ≥18 years old and with histologically or cytologically confirmed advanced solid tumors refractory/resistant to currently available therapies or for which there is no standard therapy. * Patients with primary brain tumors are not eligible. * Have at least one site of measurable disease.

Exclusion criteria

* Received chemotherapy (including targeted agents such as erlotinib), radiotherapy, immunotherapy or any investigational therapy within 3 weeks of study entry (within 6 weeks for previous treatments with nitrosoureas or mitomycin C). * Received tamoxifen within 4 weeks prior to study entry.

Design outcomes

Primary

Measure	Time frame
First-cycle Dose Limiting Toxicities	2.5 years

Secondary

Measure	Time frame
Determine the safety and tolerability of the combination of daily CP-868,596 and docetaxel on an every 3-week schedule	2.5 years
Determine the safety and tolerability of the combination of daily CP-868,596 plus daily AG-013736 plus docetaxel on an every 3-week schedule	2.5 years
To evaluate the pharmacokinetics (PK) of CP-868,596 and docetaxel when given in combination	2.5 years
To explore the effects of CP-868,596 on tumor blood flow and permeability via DCE-MRI	2.5 years
Conduct biomarker investigations on plasma/serum samples to explore critical events in pharmacodynamic response to CP-868,596 (eg, VEGF, phospho-SHP, etc.)	2.5 years
To explore the relationship between polymorphisms in genes involved in the metabolism and transport of CP-868,596 and pharmacokinetic/pharmacodynamic parameters	2.5 years
To assess any preliminary clinical evidence of anti-tumor activity using RECIST	2.5 years
To evaluate the pharmacokinetics (PK) of CP-868,596, AG-013736 and docetaxel when given in combination	2.5 years

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026